Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants (CAPTURE2)

February 1, 2024 updated by: Javelin Medical

Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for ~20% of the entire AF population, which is ~300K/year in the United State and EU. The implant is designed to exclude emboli > 1.4mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is > 1.5 mm

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented AF
  • CHA2DS2-VASc score ≥ 4 and history of ischemic stroke (including TIA with positive neuro-imaging)
  • No contra-indication for patient to receive an OAC, either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC) for the duration of the study
  • Age > 50 years
  • Maximal (systolic) CCA diameter range: ≥ 4.8mm and ≤ 9.8mm
  • CCA accessibility: up to 40mm from skin to CCA center, safe approach
  • Implantation segment free of atherosclerotic disease as determined by ultrasound imaging
  • Patient is able and willing to provide informed consent

Exclusion Criteria:

  • Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)]
  • Evidence of carotid dissection
  • Pre-existing stent(s) in CCA
  • Female who is pregnant or who is planning to become pregnant during the course of the study
  • Life expectancy of less than two years
  • Active systemic infection
  • Known sensitivity to nickel or titanium metals, or their alloys
  • Known hereditary or acquired coagulation disorders
  • Any planned surgical or endovascular treatment within 30 days after the implantation procedure
  • A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments* Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day)
  • Active participation in another investigational drug or device treatment study
  • Inability to complete all scheduled follow-up
  • Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the study
  • History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke
  • Event of stroke/TIA in the past 14 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vine™ Filter + OAC
Vine™ Filter in each common carotid artery (CCA) with oral anticoagulant treatment (either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC)) for the duration of the study
Device: Vine™ Embolic Protection System
The system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit ("Needle Unit") available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled "Loaded Needle Unit") and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications
Time Frame: 30 days from implantation procedure

Major Adverse Events (MAEs) within 30 days of the final index (implantation) procedure, defined as the composite that includes any of the following:

  • Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries
  • Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation
  • Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability
30 days from implantation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.
Time Frame: one and two years from implantation procedure
  • Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries
  • Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation
  • Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability
one and two years from implantation procedure
Number of properly positioned implants
Time Frame: 30 days from implantation procedure
proper implant position in each common carotid artery (CCA)
30 days from implantation procedure
Number of participants that had disabling strokes
Time Frame: 30 days, one and two years from implantation procedure
Disabling stroke
30 days, one and two years from implantation procedure
Number of Implantation success
Time Frame: immediately after the procedure
implantation attempt resulting in proper implant position immediately after the procedure without any device/procedure related complication that requires surgery or endovascular treatment for correction, or that results in death or major disability
immediately after the procedure
Number of properly positioned implants
Time Frame: one and two years from implantation procedure
Proper implant position in each CCA
one and two years from implantation procedure
Number of observed thrombi on the device
Time Frame: 30 days, one and two years from implantation procedure
Thrombus on implant detected by ultrasound imaging
30 days, one and two years from implantation procedure
Number of death cases
Time Frame: one and two years from implantation procedure
Death
one and two years from implantation procedure
Number of strokes (any kind)
Time Frame: one and two years from implantation procedure
Total number of strokes
one and two years from implantation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javelin Medical

Collaborators

Genae

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

November 24, 2022

Study Completion (Estimated)

October 24, 2024

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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